Skip to main content
OpenTrials
Completed

NCT Number: NCT04957160

Cabozantinib Post First-line Immuno-oncology Checkpoint Inhibitor Containing Combination

This study will collect real-world data for the new treatment pathways for all patients with Advanced Renal Cell Carcinoma (ARCC) who were treated with a 1L IO (first-line, Immuno-Oncology checkpoint inhibitor) combination therapy and progressed to a 2L treatment with particular focus to understanding where cabozantinib is prescribed after 1L IO containing combination therapy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Renal Cell Carcinoma (aRCC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of aRCC.
  • Patients aged ≥18 years at aRCC diagnosis treated with a 1L IO containing combination therapy who have progressed to a 2L treatment.

Exclusion criteria

  • Patient's hospital medical records are unavailable for review;
  • Patients have started a 2L treatment as part of a Renal Carcinoma Treatment (RCT).

Treatment and study plan

Primary outcomes

  1. Description of the treatment sequence pathway from 1L up to 2L for patients with aRCC

    Time frame: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

    To be described for patients with aRCC receiving 2L treatment following a 1L IO containing combination therapy.

  2. Description of the treatment sequence pathway from 1L up to the 2L for cabozantinib patients with aRCC

    Time frame: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

    To be described for patients with aRCC receiving 2L treatment and subsequent lines of treatment following a 1L IO containing combination therapy.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

  2. Time to Treatment Discontinuation (TTD) by line

    Time frame: From start date of first cycle of treatment to start date of last cycle of treatment during data collection period (from 15th of January 2015 until September 2022)

  3. Physician defined Best Response by line - complete response, partial response, stable disease, progressive disease

    Time frame: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

  4. Overall Response Rate (ORR) by line -complete response or partial response

    Time frame: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

  5. Duration of treatment by line

    Time frame: From start date of first cycle of treatment to start date of last cycle of treatment during data collection period (from 15th of January 2015 until September 2022)

  6. Drug start and end dose by line

    Time frame: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

    Descriptive statistics using following parameters: no dose change, dose change, dose increase and dose decrease

  7. Disease Control Rate (DCR) by line - complete response, partial response and stable disease

    Time frame: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

  8. Progression Free Survival (PFS) by line for cabozantinib patients

    Time frame: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

  9. Reason for stopping cabozantinib

    Time frame: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

    Descriptive statistics using the following parameters: radiological disease progression, clinical deterioration, AE, subject's decision, Investigator's decision, end of predefined treatment, other

  10. Reason for dose change (Disease progression, AE, subject non-compliance, subject decision, clinical / Investigator decision, radiotherapy(s), surgery(s), COVID-19 pandemic, other)

    Time frame: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

  11. Describe interruptions for cabozantinib

    Time frame: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

  12. Cause of death (RCC or non RCC related)

    Time frame: From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Multicentre, Retrospective, Non-interventional Review of Electronic Prescribing Records of Any Second-line (2L) Patients and Chart Notes of 2L Cabozantinib Patients, Investigating the Treatment Sequence Pathway Following a First-line, Immuno-oncology Checkpoint Inhibitor (1L IO) Containing Combination Therapy in Patients With Advanced Renal Cell Carcinoma (aRCC) (CARINA)

Acronym: CARINA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2021
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.